MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for VERESS INSUFFLATION NEEDLE 150MM FB804R manufactured by Aesculap Ag.
[136725470]
(b)(4). Manufacturing site evaluation: ongoing. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[136725471]
It was reported that the tip blunt/broke off inside patient intraoperatively. It was reported that a percutaneous peritoneal dialysis catheter insertion was attempted; the patient received iv flucloxacillin, oral oxycodone, and sublingual lorazepam pre procedure. The bladder was empty per scan and the visceral slide was identified on ultrasound. The received 20ml 1% lidocaine with adrenaline and a midline incision was made. The surgeon used a self-retaining retractor, and two attempts were made with the sheathed introducer needle but unable to puncture through to the peritoneal membrane. The veress needle was attempted twice and after the second attempt the tip of the blunt outer retractable part of the veress needle was noted to be missing. It was reported that the equipment was checked prior to the start of the procedure and was intact. Immediate action taken: the procedure abandoned, and an x-ray was ordered and the patient was under close observation by ward medical and nursing teams. The x-ray was suggestive of a foreign body and a ct was ordered which confirmed the foreign body. The transplant/dialysis access surgeons located at central manchester hospital were alerted and asked for advice. Initially it was suggested that they would be able to remove and place a peritoneal dialysis catheter within the next few weeks. Then amended advice and asked to request review from srft general surgeons. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00097 |
| MDR Report Key | 8356036 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-25 |
| Date Facility Aware | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2019-02-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERESS INSUFFLATION NEEDLE 150MM |
| Generic Name | NSUFFLATION ACCESSORIES |
| Product Code | HET |
| Date Received | 2019-02-20 |
| Returned To Mfg | 2019-02-12 |
| Model Number | FB804R |
| Catalog Number | FB804R |
| Lot Number | 114556 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-20 |