MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364902
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter that the tube is tight in holder.The following information was provided by the initial reporter: customer states they are unable to remove the vacutainer from the bd maxzero needless connector.
Additional Manufacturer Narrative
D.3 common device name: bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.3.Medical device manufacturer: bd caribe ltd.¿ juncos pr / 00777.D.4.Medical device lot #: 3053164.D.4.Medical device expiration date: 28-feb-2026.G.1 manufacturing location: bd caribe ltd.¿ juncos pr / 00777.H.4.Device manufacture date: 18-apr-2023.H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for unable to disconnect was observed.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and the issue of unable to disconnect was not observed as no defects were found with the hub.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode unable to disconnect.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
(b)(6) : 2023-09-01 13:09:23 (gmt).Reviewed, pending investigation summary.(b)(6) : 2023-08-28 19:38:17 (gmt).Customer did not respond after multiple attempts to contact for returns.No additional information is available.(b)(6) : 2023-08-23 13:25:51 (gmt).Subject: email 8/23/2023, 8:23:02 am user: (b)(6) created on: 2023-08-23 13:23:02 call activity comment: final follow up for returns.Kimberly jackson : 2023-08-21 12:29:57 (gmt).Subject: email 8/21/2023, 7:25:23 am.User: (b)(6).Created on: 2023-08-21 12:25:24.Call activity comment: 1st follow up for returns.(b)(6): 2023-08-17 12:22:45 (gmt).Subject: email 8/17/2023, 7:00:29 am.User: (b)(6).Created on: 2023-08-17 12:00:30.Call activity comment: fedex return label sent.Kimberly jackson : 2023-08-17 12:10:59 (gmt) fedex return: 773081660949 (b)(6) : 2023-08-16 17:49:25 (gmt).Subject: email 8/16/2023, 12:16:59 pm.User: (b)(6).Created on: 2023-08-16 17:17:00.Call activity comment: final request if returns are available (b)(6) : 2023-08-14 16:54:51 (gmt).Subject: email 8/14/2023, 9:54:16 am.User: (b)(6) created on: 2023-08-14 14:54:16 call activity comment: asked if returns available (b)(6) : 2023-08-14 15:26:02 (gmt).Did the specimen(s) need to be recollected? no.Did exposure to blood/ bf occur? no.If exposure occurred was there any post exposure testing or medical intervention? na.Quantity received and quantity affected: 1 affected.Shipment method (directly or via distributor): unknown.If it is a distributor or directly from bd¿ who is it? unknown.(b)(6) : 2023-08-14 14:21:04 (gmt).Subject: email 8/14/2023, 7:47:04 am.User: (b)(6) created on: 2023-08-14 12:47:05 call activity comment: 2nd request for information (b)(6) : 2023-08-11 12:06:12 (gmt).If salesforce pir complaint, date email received: na.Customer problem: customer states they were unable to remove the vacutainer adapter from the bd maxzero needless connector.Customer believe the problem is with the maxzero although it is not clear.Steps taken with customer/troubleshooting: requested additional information; facility name and address, recollection, exposure, intervention, quantity, distributor, returns, credit customer location (country): usa.Did the specimen(s) need to be recollected? pending.Did exposure to blood/ bf occur? pending.If exposure occurred was there any post exposure testing or medical intervention? pending.Next steps (if necessary): awaiting response.Resolution achieved (y/n)? : n.Quantity received and quantity affected: 1 affected.Shipment method (directly or via distributor): pending.If it is a distributor or directly from bd¿ who is it? pending.Photos or returns requested?: photo of adapter unable to disconnect attached, return requested.Follow up required (y/n)?: y.(b)(6) : 2023-08-11 12:05:58 (gmt).Subject: email 8/10/2023, 12:01:12 pm.User: (b)(6).Created on: 2023-08-10 17:01:12.Call activity comment: additional information requested.(b)(6): 2023-08-11 12:00:59 (gmt).Subject: call 8/10/2023, 1:31:35 pm.User: (b)(6).Created on: 2023-08-10 18:31:36.Call activity comment: additional information requested.Call dropped.It was reported by the customer that they are unable to remove the vacutainer from the bd maxzero needless connector (b)(6) : 2023-08-11 01:39:06 (gmt).Reviewed, pending additional information.Thu aug 10 17:10:32 utc 2023 - patient fields updated: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.(b)(6) : 2023-08-10 17:10:27 (gmt).Customer states they are unable to remove the vacutainer from the bd maxzero needless connector.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17549552
• Report Number: 2243072-2023-01450
• Device Sequence Number: 6657656
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 364902
• Device Lot Number: 3053164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown