MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-16 for COMPACT INTUITIV PACK DISPOSABLE TUBING SET OPO80 manufactured by Johnson & Johnson Surgical Vision, Inc..
[183821076]
Date of event is unknown as it was not provideddevice evaluation:the tubing pack was returned to evaluation. A visual evaluation was performed. The visual assessment observed a hole on the tyvek lid. Manufacturing record review:per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the tubing pack lot# 60209819. All devices met material, assembly and performance specifications at the time of product released. Investigations:the failure mode of? Pinhole in the packaging? Was not replicated through mechanical stress inflicted by simulated standard shipping and handling conditions, however, was able to be replicated when a single opo80 tubing pack was dropped from a height of 48 inches. A potential contributor for the? Pinhole in the package? May be related to the opo80 tubing pack being able to move within the tyvek packaging and during its inappropriately handling by the user such as unintentional dropping of the tubing pack tray on the floor. Device labeling does contain instructions to not use the device if the package is damaged. As a proactive and precautionary measure, the current packaging will be reconfigured (and validated) to increase its durability. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183821077]
The surgery center reported observing holes worn into the tyvek lid of a compact intutiv pack disposable tubing set model opo80. The surgery center had concerns the packaging had been comprised and the tubing pack was no longer sterile. A visual inspection confirmed a puncture hole on the tyvek lid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00183 |
| MDR Report Key | 9835139 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 1700 E. ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT INTUITIV PACK DISPOSABLE TUBING SET |
| Generic Name | PHACO TUBING |
| Product Code | HQC |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-26 |
| Model Number | OPO80 |
| Catalog Number | OPO80 |
| Lot Number | 60209819 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-16 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |