MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ ECCENTRIC LUER SLIP TIP SYRINGE; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unspecified number of bd¿ eccentric luer slip tip syringe experienced impurity peak.The following information was provided by the initial reporter: i am writing to you again following receipt of syringe reference (b)(4).On the last order lfd2036/2023 we received 16 cartons, all of which were returned internally as non-compliant.The last batch received from order lfd5529/2022 no.2207133 was compliant.Lot 2301033: (1) lot refused because quantified in barium.Conclusion: lot not in conformity: barium.Batch 2212022: conclusion: lot not in conformity: ammonium.Batch 2211058: conclusion: non-conforming lot for barium, potassium and zinc - the following elements are returned in the saline water matrix (pmi006) because the limits of quantification are lower.Silver: < 0.1 pg/l, calcium: < 0.5 mg/l, cobalt: < 0.1 pg/l, potassium: 0.261 mg/l, magnesium: < 0.5 mg/l, manganese: < 0.5 pg/l, molybdenum: < 0.0001 mg/l, lead: < 0.25 ug/l, antimony: < 0.25 pi/l, tin: < 0.5 ug/l.Lot 2302042: (1) lot refused because quantified in barium and zinc conclusion: non-conforming lot.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: d4.Medical device lot #: 2302042.D4.Medical device expiration date: 31-jan-2028.H4.Device manufacture date: 31-jan-2023.D4.Medical device lot #: 2212022.D4.Medical device expiration date: 30-nov-2027.H4.Device manufacture date: 30-nov-2022.D4.Medical device lot #: 2211058.D4.Medical device expiration date: 31-oct-2027.H4.Device manufacture date: 07-nov-2022.D4.Medical device lot #: 2301033.D4.Medical device expiration date: 31-dec-2027.H4.Device manufacture date: 28-dec-2022.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lots 2302042, 2212022.2211058 and 2301033, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Raw material is received with a quality certificate ensuring the material provided is safe and adequate for medical use.None of the chemicals mentioned by the customer are used in the manufacturing of this product and no changes in our manufacturing process or the raw material for this product have been made.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.A review of inspection records established that all production and quality processes were carried out without issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.Based on our quality team's investigation, a root cause related to the manufacturing process cannot be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that unspecificed number of bd¿ eccentric luer slip tip syringe experienced impurity peak.The following information was provided by the initial reporter: i am writing to you again following receipt of syringe reference (b)(4).On the last order (b)(4) (attached) we received (b)(4) cartons, all of which were returned internally as non-compliant (see attached sheets).The last batch received from order (b)(4) no.2207133 was compliant.Lot 2301033: (1) lot refused because quantified in barium; conclusion : lot not in conformity : barium.Batch 2212022: conclusion : lot not in conformity : ammonium.Batch 2211058: conclusion : non-conforming lot for barium, potassium and zinc - the following elements are returned in the saline water matrix (pmi006) because the limits of quantification are lower.Silver: < 0.1 pg/l ; calcium: < 0.5 mg/l; cobalt: < 0.1 pg/l; potassium: 0.261 mg/l; magnesium: < 0.5 mg/l ; manganese: < 0.5 pg/l; molybdenum: < 0.0001 mg/l; lead: < 0.25 ug/l ; antimony: < 0.25 pi/l; tin: < 0.5 ug/l.Lot 2302042: (1) lot refused because quantified in barium and zinc.Conclusion: non-conforming lot.

• Brand Name: BD¿ ECCENTRIC LUER SLIP TIP SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17654894
• Report Number: 3003152976-2023-00360
• Device Sequence Number: 7370844
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: (01)30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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 Catalogue Number: 300613
• Device Lot Number: MULTIPLE REPORTED
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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