MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-09-08 for ICP LUER ADAPTOR 16-1057 manufactured by Codman & Shurtleff, Inc.
[4738755]
Affiliate reported that: "leakage problem occurring at the connector between the bactiseal evd catheter 82-1745 and the codman reference 82-1731 external drainage system eds3. The connector = codman item 16-1057. Due to blood in the 82-1731, a new 82-1731 had to be coupled to the 82-1745 and even though the 82-1731 was connected very carefully to the 16-1057, the doctor heard a kind of? Clack? Noise and she could see a crack in the female luer lock connector part. This is exactly the same complaint as (b)(4): same hospital, different doctor. The sample for this second complaint was unfortunately discarded. Both doctors take these complaints very seriously because the extra handlings involved in solving this problem exposed the patient to additional high risks. For example, there is the possibility that the patient gets an infection of the meninges. Our product specialist emphasized that the hospital is requesting a detailed analysis of these events, because of the possible high risks involved".
Patient Sequence No: 1, Text Type: D, B5
[12297568]
(b)(4). It has been communicated that the device is not available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided, a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point, the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[30029697]
Complaint sample was not returned to codman; therefore, the evaluation could not be performed. In the absence of the complaint sample, a lot history records review for p/n 16-1057; lot # 118703, was conducted and it was verified that all products in this lot # 118703 were conforming to the required specifications when released from manufacturing on july 28, 2011. A complaint records review was also conducted, and it was verified that during the last five years this is the first complaint reported for this type of issue, for this product code and lot number, and it is considered to be an isolated incident. The cause(s) of the difficulty reported by the customer could not be determined. Trends will be monitored for this and similar complaints. At the present time, this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2014-11948 |
| MDR Report Key | 4068483 |
| Report Source | 01,07 |
| Date Received | 2014-09-08 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 2011-07-28 |
| Date Added to Maude | 2014-09-08 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICP LUER ADAPTOR |
| Generic Name | INTRACRANIAL CANNULA |
| Product Code | GCD |
| Date Received | 2014-09-08 |
| Catalog Number | 16-1057 |
| Lot Number | 118703 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 82 | 1. Required No Informationntervention | 2014-09-08 |