MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for ARROW PERITONEAL LAVAGE CATH KIT:8FR AK-09000 manufactured by Arrow International Inc..
[67825931]
(b)(4). The device has been returned to the manufacturer. However, the investigation of said device is still in progress at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[67825932]
Customer complaint alleges "peritoneal lavage catheter 8 fr was splitting on the end in which the connector was applied". Alleged defect was detected during use. It was reported there was no injury to the patient. It was reported there was no delay or interruption in therapy. The patient's condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
[71138365]
(b)(4). A peritoneal catheter and a non-arrow connector were returned for evaluation. Microscopic examination of the catheter revealed a crack 0. 2cm from the mold seam emanating from the proximal luer hub opening and extending approximately 1. 6cm down the luer hub. Per the complaint, a non-arrow connector was inserted into the hub of the arrow catheter. Per catheter graphic k-09000-001a rev. 4, the female luer taper on the arrow catheter is per iso 594-1. It will accept a male connector designed to the same iso standard. The female luer taper of the catheter could not be accurately checked with gauge ga-1130-005-38 due to the split in the hub. The tip of the non-arrow connector was checked with gauge ga-tp-0057-003 3b to see if it's taper conformed to iso 594-1. It did not fit the appropriate depth into the gauge, indicating the taper of the non-arrow connector is not iso 594-1 compliant. An attempt was made to insert the non-arrow connector into the luer hub of the arrow catheter. The connector would only enter 2mm into the luer hub before the existing split in the hub started to open. Other remarks: measurement of luer gauge ga-1130-005-38 showed that an iso 594-1 compliant male luer should enter a minimum of 7mm into a iso 594-1 compliant female luer. Both the functional test and the male luer gauge indicate the customer's non-arrow connector is incompatible with the arrow peritoneal catheter. The report that the female luer hub split during use was confirmed through examination of the returned sample. The customer returned the non-arrow connector they were trying to use with the arrow catheter. The connector was too large to fit into the arrow luer hub and forcing it into the hub would have split the hub. A dhr review was performed and it did not reveal any manufacturing related issues. Based on the use of an incompatible connector with the arrow catheter, it was determined that operational context caused this event.
Patient Sequence No: 1, Text Type: N, H10
[71138366]
Customer complaint alleges ""peritoneal lavage catheter 8 fr was splitting on the end in which the connector was applied". Alleged defect was detected during use. It was reported there was no injury to the patient. It was reported there was no delay or interruption in therapy. The patient's condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2017-00094 |
| MDR Report Key | 6331895 |
| Date Received | 2017-02-15 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2016-01-11 |
| Date Added to Maude | 2017-02-15 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW PERITONEAL LAVAGE CATH KIT:8FR |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-02-15 |
| Returned To Mfg | 2017-02-10 |
| Catalog Number | AK-09000 |
| Lot Number | 23F16A0304 |
| Device Expiration Date | 2017-12-31 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-15 |