MAUDE Adverse Event Report: BD CARIBE LTD. BD TRAY BONANNO CATHETER S/SU; SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES

Model Number	408289
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Event or Problem Description
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 mhra notifiable incident, due to the drain potentially being part of a faulty batch.In relation to the two points above: i) 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.Ii) 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 mhra.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.
Additional Manufacturer Narrative
H.6.Investigation: bd has not been provided with photos or samples for catalog 408289 lots 7201648 and 5280953 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.The device history review shows no indication of the reported defect or nonconformances as it related to the manufacturing process.H3 other text : see h.10.

• Brand Name: BD TRAY BONANNO CATHETER S/SU
• Common Device Name: SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9666330
• Report Number: 2618282-2020-00003
• Device Sequence Number: 11463008
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other