MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-09-04 for ICP LUER ADAPTOR 16-1057 manufactured by Codman & Shurtleff, Inc..
[16587161]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[16632796]
The affiliate reported "placement of a external ventricular drainage catheter 821745 and connection to a 821731 drainage collection system by means of a 16-1057 connector 1079 procedure/surgery date (b)(6) 2014 (b)(4) -describe event on (b)(6) 2014, doctor informed me of a leakage problem occurring at the connector between the bactiseal evd catheter 82-1745 and the codman reference 821731 external drainage system eds3. The connector = codman item 16-1057. Due to blood in the 821731, a new 821731 had to be coupled to the 821745 and even though the 821731 was connected very carefully to the 161057, the doctor heard a kind of? Clack? Noise and she could see a crack in the female luer lock connector part. Trying with another 161057 with the same lot number, just the same problem happened again so a third connector had to be connected and then finally the connection was ok. When i was provided with the products, i could see a little crack at the female luer lock part of both returned connectors. "
Patient Sequence No: 1, Text Type: D, B5
[34395629]
Two icp luer adaptors p/n 16-1057; lot # 464837 were returned to codman for evaluation. As received and after eto decontamination, it was verified that both icp luer adaptors were cracked on the luer adaptor side. One of the adaptors has one crack and the second one has two cracks. The cause(s) of the damages could not be fully determined. It appears that both adaptors were over-tightened with the counterpart product(s); however, it could not be confirmed. A lot history records review for p/n 16-1057; lot # 464837 was conducted, and it was verified that all products in this lot number were conforming to the required specifications when released to stock on january 16, 2014. A complaints records review was also conducted and it was verified that this is the first complaint reported for this product during the last five years and it is considered to be an isolated incident. Trends will be monitored for this or similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2014-11942 |
| MDR Report Key | 4060885 |
| Report Source | 01,07 |
| Date Received | 2014-09-04 |
| Date of Event | 2014-08-11 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2014-01-16 |
| Date Added to Maude | 2014-09-04 |
| 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 | RUE GIRARDET 29 |
| Manufacturer City | LE LOCLE CH 2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH 2400 |
| 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 | 2014-09-04 |
| Returned To Mfg | 2014-09-03 |
| Catalog Number | 16-1057 |
| Lot Number | 464837 |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | RUE GIRARDET 29 LE LOCLE CH 2400 SZ CH 2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-04 |