MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD BBL¿ BIO-BAG¿ ENVIRONMENTAL CHAMBER TYPE CFJ; GAS-GENERATING DEVICE

Catalog Number	261212
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: investigation summary: after reviewing the dhr no internal rejects related to broken/damaged was found during manufacturing process.A complaint history check was performed, and this is the 1st complaint reported for the injury (broken / damaged) on lot number 7156506 and is the 1st complaint received with this type of defect on the last 12 months related to catalog 261212.Investigation conclusion: due to no samples to evaluate were received it was not possible to determinate if the product manufacture could contribute to the reported failure.However based on the product design is very unlikely to have this kind of situations since the ampoule in the generator needs to perforate the following components (tube, sleeve, label & anaerobic bag) before injury to the customers.Root cause description: based on the nature of the reported defect without sample and/or any picture of the failed product the probable root cause could not be determinate.
Event or Problem Description
It was reported that while using a bd bbl¿ bio-bag¿ environmental chamber type cfj a lab assistant was cut through their glove attempting to crush the glass ampoule.The lab assistant received medical intervention at an emergency room following the incident.
Event or Problem Description
It was reported that while using a bd bbl bio-bag environmental chamber type cfj a lab assistant was cut through their glove attempting to crush the glass ampoule.The lab assistant received medical intervention at an emergency room following the incident.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacture: no.

• Brand Name: BD BBL¿ BIO-BAG¿ ENVIRONMENTAL CHAMBER TYPE CFJ
• Common Device Name: GAS-GENERATING DEVICE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7679811
• Report Number: 9610847-2018-00222
• Device Sequence Number: 1370150
• Product Code: KZJ
• UDI-Device Identifier: 00382902612124
• UDI-Public: 00382902612124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 261212
• Device Lot Number: 7156506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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: Required Intervention