MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-04 for BD TRAY BONANNO CATHETER S/SU 408289 manufactured by Bd Caribe Ltd..
[179109366]
There were multiple "possible" lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 5280953, medical device expiration date: 2020-10-31, device manufacture date: 2015-11-10. Medical device lot #: 7201648, medical device expiration date: 2022-07-31, device manufacture date: 2017-08-25. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179109367]
It was reported that after removal of drain part of it remained inside patient with a bd tray bonanno catheter s/su. The following information was provided by the initial reporter: a patient was admitted with cirrhosis and ascites. (b)(6) 2020 trial for ascetic drain insertion attempted with no success. Next monday (b)(6) 2020 drain inserted after us marking of the location. Drain inserted at 1730, by me with spr presence, with some difficulty due to patient body habitus, but no obvious concerns. Night staff did not remove drain until the next day, however, it was clamped. The drain was removed by me the next day. However, part of it was missing (nearly 10 cm). I am unsure what might have caused this. Qgm (rp): alerted to the incident by ward manager, for which two issues came to mind immediately; i) potential never event as is a retained foreign body, and ii) an (b)(6) notifiable incident, due to the drain potentially being part of a faulty batch. In relation to the two points above: discussed the incident with the patient safety lead and associate director of quality governance. Review of the never events list confirmed this is not a never event, due to the second bullet point of exceptions under the foreign body section, which outlines an exception of the retained foreign body being known about, left intentionally as not immediately retrievable and for removal at a later date. Liaised with the ward manager who was finding the details of the drain and then forwarding them to the patient safety manager, who will notify (b)(6). Patient situation: the patient is now to be moved to ward 14, but the surgeons will not remove the retained part of the drain at the moment due to the patient's pre-existing oedema. The patient was informed about what happened. I spoke with radiologist and arranged an axr, then ctap to locate the missing part of the drain and informed the surgical team.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2020-00003 |
| MDR Report Key | 9666330 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD TRAY BONANNO CATHETER S/SU |
| Generic Name | SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | FEZ |
| Date Received | 2020-02-04 |
| Model Number | 408289 |
| Catalog Number | 408289 |
| Lot Number | SEE H.10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |