MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-29 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[3726627]
This spontaneous report was initially received from a pharmacist and concerned a female pt of unspecified age from the united states: (b)(4). The pt's height, weight and medical history were not reported. She was prescribed all-flex arcing spring diaphragm (silicone). Concomitant medications were not reported. On an unspecified date, the pt brought the diaphragm back to the pharmacist and stated it was damaged (device malfunction). The pharmacist reported there was a hole in diaphragm (medical device complication); lot number a56eu1. There was no event reported with this product quality complaint (pqc number (b)(4)). This case, involving the same pt was linked to (b)(6). The device was evaluated following product complaint received from (b)(6) via central complaint vigilance -(b)(6). According to the visual analysis, it was observed that the sample had two deviations; small encrusted silicone particles in the dome and dome cut. After investigating, it was verified that all diaphragms produced undergo a visual inspection in which the products with rips are destroyed by stretching; this way, the product could not leave the mfg process with the rip. There was no stage after inspection that could generate the rip defect because no cutting tools are used. Concerning the silicone particle found, they are part of the mfg process; however, they should have been removed in the visual inspection. Since diaphragms are submitted to 100% visual inspection by two quality techs for ensuring that this kind of defect is found and classified, it could be verified that there was a fail in the visual inspection, therefore, the complaint was confirmed for particles. As the event rate is within the acceptance level for this kind of defect, no action is necessary. Additionally, functional tests performed on dome thickness and rim thickness were above minimum limits specified according to (b)(4). The pt outcome was not reported. This report was non reportable. This case version was created on (b)(4) 2013 for the purpose of quality improvement. Upon review, the following corrections were made: version 0 the version date for version initially received was corrected from 04/15/2013 to 08/21/2012, ich expedited date was corrected from 04/15/2013 to 08/21/2012, latest info received was corrected from 04/15/2013 to 04/09/2013, received by local safety unit was changed from 04/15/2013 to 08/21/2012 and received by case processing center was changed from 04/15/2013 to 08/21/2012. All-flex arcing spring diaphragm (silicone) 75mm model number was included. This case was previously reported as non-serious non reportable and was corrected to serious reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
[11089944]
Lot number a56eu1 provided. According to the visual analysis, it was observed that the sample had two deviations: small encrusted silicone particles in the dome and the dome cut. After investigating, it was verified that all diaphragms produced undergo a visual inspection in which the products with rips are destroyed by stretching; this way, the product could not leave the mfg process with the rip. There is no stage after inspection that could generate the rip defect because no cutting tools are used. Since diaphragms are submitted to 100% visual inspection by two quality technicians for ensuring that this kind of defect is found and classified, it could be verified that there was a fail in the visual inspection, therefore. The complaint was confirmed for particles. In the visual analysis of the product sent, it was observed that the dome thickness was cut. After investigation, it was verified that the product didn't leave the company with the claimed "cut defect because the diaphragm would be completely ripped when placed in the equipment for making visual inspection. After the visual inspection in the mfg process, there is not any stage that could generate the defect cut because no cutting tools are used. Additionally it was performed functional tests, such as dome thickness and rim thickness, and all results found are above the minimum limits specified. Nevertheless, the complaint will be logged in our trend analysis for further eval and, if applicable, improvements in our process and products. All-flex arcing spring diaphragm (silicone).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00309 |
| MDR Report Key | 3347339 |
| Report Source | 05,06 |
| Date Received | 2013-08-29 |
| Date of Report | 2012-08-21 |
| Report Date | 2013-04-16 |
| Date Reported to FDA | 2013-08-28 |
| Date Reported to Mfgr | 2013-04-16 |
| Date Mfgr Received | 2012-08-21 |
| Date Added to Maude | 2013-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MCNEIL JANSSEN |
| Manufacturer Street | 1125 TRENTON-HARBOURTON ROAD |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal | 08560 |
| Manufacturer Phone | 2153257722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2013-08-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | A56EU1 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) |
| Manufacturer Address | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-29 |